VENCLYXTO in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
*VIALE-A was a randomised (2:1), double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus AZA in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus AZA was 14.7 months (95% CI: 11.9-18.7) vs 9.6 months for AZA alone (95% CI: 7.4-12.7; HR=0.66; P<0.001).1
SAFETY/TOLERABILITY FOR VENCLYXTO + AZACITIDINE
DISCONTINUATION RATES WITH VENCLYXTO PLUS AZA
DISCONTINUATIONS, DOSE INTERRUPTIONS, AND DOSE REDUCTIONS DUE TO AEs FOR VEN+AZA1,2
| • | 24% of patients discontinued treatment due to AEs vs 20% in AZA alone arm |
| • | 2% of patients had dose reductions due to AEs for VEN+AZA |
| • | 72% of patients experienced dose interruptions due to AEs vs 57% in AZA alone arm |
| • | The most common adverse reactions that led to dose interruption (>10%) of VEN were febrile neutropaenia, pneumonia, and thrombocytopaenia |
Continue treatment until disease progression or unacceptable toxicity1
VENCLYXTO PLUS AZA DEMONSTRATED A MANAGEABLE AND WELL-CHARACTERISED ADVERSE EVENT PROFILE
MOST COMMON TREATMENT-EMERGENT AEs1,2
| • | 83% of patients in the VENCLYXTO plus AZA group had a serious AE vs 73% receiving AZA alone2 |
| • | The most frequently reported serious treatment-emergent AEs (Grade ≥3) in patients receiving VENCLYXTO plus AZA vs AZA alone, respectively, were febrile neutropaenia (30% vs 10%), pneumonia (16% vs 22%), sepsis (6% vs 8%), and haemorrhage (6% in VEN+AZA)1,2 |
In the VIALE-A study:
| • | The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving VENCLYXTO plus AZA were thrombocytopaenia, neutropaenia, febrile neutropaenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and decreased appetite1 |
| • | The most frequently reported serious adverse reactions (≥5%) in patients receiving VENCLYXTO plus AZA were febrile neutropaenia, pneumonia, sepsis, and haemorrhage1 |
Rates of serious AEs, including anaemia, pneumonia, and sepsis, were comparable in both treatment arms2
VENCLYXTO ADVERSE DRUG REACTIONS
DEMONSTRATED IN PATIENTS WITH AML1
| • | In the VIALE-A study, grade ≥3 neutropaenia was reported in 45% of patients. The following were also reported in the VEN+AZA arm vs AZA alone, respectively: febrile neutropaenia 42% vs 19%, grade ≥3 infections 64% vs 51%, and serious infections 57% vs 44%1 |
*Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from available data).1
†Only the highest frequency observed in the trials is reported (based on studies VIALE-A and M14-358).
‡Includes multiple adverse reaction terms.
AML=acute myeloid leukaemia; AE=adverse event; AZA=azacitidine; BCL-2=B-cell lymphoma 2; CI=confidence interval; HR=hazard ratio; VEN=VENCLYXTO.
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References: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. December 2022. 2. DiNardo CD, Jonas BA, Pullarkat V, et al. Azacitidine and venetoclax in previously untreated acute myeloid leukemia. N Engl J Med. 2020;383(7):617-629. doi:10.1056/NEJMoa2012971
ALL-VNCAML-220066 October 2023